Senior Quality Control Analyst I - Data Review

The Steely Group; Woburn (MA); On-site; USD 90,000 - 120,000; Full time

Job summary

The Steely Group is seeking a Senior QC Analyst I, Data Review to join the Gene Therapy Quality Control organization in Massachusetts. You will review and approve analytical data from internal and external labs to ensure data integrity and timely product disposition.

You will collaborate with QA, CTOs, and QC labs, author technical documents, support investigations, and drive continuous process improvements in a fast-paced environment.

Qualifications

• BS or MS in Cell Biology, Molecular Biology, Biochemistry or a related discipline with minimum 5+ years industry experience.
• Experience in a GMP/GLP environment is a must.
• Extensive experience reviewing analytical data from molecular biology, bioassay, biochemical, or microbiological test methods – experience in molecular biology and/or bioassay is a plus.
• Strong understanding of cGMP regulations, FDA data integrity guidance, ALCOA+ principles, and quality systems requirements.

Responsibilities

• Perform comprehensive review and approval of cGMP analytical data packages generated by internal and external laboratories for release, stability, in-process, and characterization testing including but not limited cell-based assays, quantitative PCR, ELISA, microbiological test methods, HPLC, and capillary electrophoresis.
• Verify analytical data for accuracy, completeness, compliance, and adherence to approved test methods, specifications, protocols, and regulatory requirements.
• Review laboratory documentation including raw data, electronic records, calculations, chromatograms, notebooks, worksheets, and associated metadata.
• Assess analytical results for data integrity, audit trail compliance, and adherence to ALCOA+ principles.
• Support product release activities by ensuring timely completion and approval of analytical data review deliverables.
• Collaborate with internal stakeholders and external contract laboratories to resolve analytical data discrepancies and ensure timely closure of review comments.
• Author and support quality events including deviations, laboratory investigations, CAPAs, OOS, OOT, and change controls as required.
• Generate and evaluate assay performance trending and data quality metrics to identify emerging issues and opportunities for continuous improvement.
• Support regulatory inspections and internal audits by providing analytical documentation and subject matter expertise related to data review processes.
• Assist in the development, revision, and implementation of SOPs, work instructions, and data review procedures.

Skills

Attention to detail

Data analysis

Written communication

GMP/GLP experience

Education

BS or MS in Cell Biology, Molecular Biology, Biochemistry

Tools

LIMS (LabVantage)

ELN

CDS

Empower

Job description

This position is within the Gene Therapy Quality Control organization and is primarily responsible for the review, verification, and approval of analytical data generated by internal and external laboratories in support of AAV-based gene therapy programs.

The Senior QC Analyst I, Data Review will work closely with Quality Control laboratory groups, Quality Assurance, and Contract Testing Organizations (CTOs) to ensure data integrity, compliance with cGMP requirements, and timely product disposition.

The role is responsible for reviewing drug substance and drug product release, stability, and characterization testing data generated from a variety of analytical methods including Molecular Biology, Bioassay, Microbiology, and Biochemical techniques.

Routine responsibilities include analytical data review, trend analysis, technical document authoring, investigation support, and continuous process improvement initiatives.

Responsibilities:

• Perform comprehensive review and approval of cGMP analytical data packages generated by internal and external laboratories for release, stability, in-process, and characterization testing including but not limited cell-based assays, quantitative PCR, ELISA, microbiological test methods, HPLC, and capillary electrophoresis.
• Verify analytical data for accuracy, completeness, compliance, and adherence to approved test methods, specifications, protocols, and regulatory requirements.
• Review laboratory documentation including raw data, electronic records, calculations, chromatograms, notebooks, worksheets, and associated metadata.
• Assess analytical results for data integrity, audit trail compliance, and adherence to ALCOA+ principles.
• Support product release activities by ensuring timely completion and approval of analytical data review deliverables.
• Collaborate with internal stakeholders and external contract laboratories to resolve analytical data discrepancies and ensure timely closure of review comments.
• Author and support quality events including deviations, laboratory investigations, CAPAs, OOS, OOT, and change controls as required.
• Generate and evaluate assay performance trending and data quality metrics to identify emerging issues and opportunities for continuous improvement.
• Support regulatory inspections and internal audits by providing analytical documentation and subject matter expertise related to data review processes.
• Assist in the development, revision, and implementation of SOPs, work instructions, and data review procedures.

Requirements / Qualifications:

• BS or MS in Cell Biology, Molecular Biology, Biochemistry or a related discipline with minimum 5+ years industry experience.
• Experience in a GMP/GLP environment is a must.
• Extensive experience reviewing analytical data from molecular biology, bioassay, biochemical, or microbiological test methods – experience in molecular biology and/or bioassay is a plus.
• Strong understanding of cGMP regulations, FDA data integrity guidance, ALCOA+ principles, and quality systems requirements.
• Experience reviewing data generated from techniques such as qPCR, ddPCR, ELISA, cell-based assays, HPLC, electrophoresis, or other analytical platforms preferred.
• Familiarity with electronic laboratory systems including LIMS (LabVantage), ELN, CDS, Empower, SoftMax Pro, JMP, BioRad QuantaSoft or comparable systems preferred.
• Strong attention to detail with the ability to identify discrepancies, trends, and compliance risks in analytical documentation.
• Independently motivated and detail-oriented with good problem-solving ability.
• Strong communication, interpersonal and organizational skills.
• Ability and desire to work in a fast-paced environment.
• Strong collaboration, team-working skills, and communication skills.

Physical Demand Requirements:

Ability to work in both office and laboratory environments. Stand for extended periods of time with periodic stooping, bending, and kneeling. Able to lift, push, pull up to 25 lbs. Work in a laboratory environment requiring personal protective equipment as needed. Ability to use computers and electronic systems for prolonged periods during data review activities. Certain tasks may require entry into GMP laboratory areas requiring adherence to gowning and safety requirements.